SEARCH

SEARCH BY CITATION

Keywords:

  • biobanks, bioethics, blood donation, genetic information

Abstract

  1. Top of page
  2. Abstract
  3. Introduction
  4. Blood donation in the UK: social and political landscapes
  5. The emergence of an ‘informational’ economy
  6. The development of UK Biobank
  7. Science governance in the UK
  8. Bodies of experts and the governance of medical research
  9. Blood and commerce: ‘gift’ as a mediating concept
  10. Conclusions
  11. Acknowledgements
  12. References

In recent years international bioethics bodies have made prominent declarations about the uses of donated tissue and related information in genetic research1. Following the ‘legislative’ mode of bioethics2, these organisations have put forward a number of general principles with a view to promoting the fair and equitable use of donated tissue in such research. However, government policies in this field are shaped differently in different national regimes. In this paper, I use recent debates in the UK about a national genetic ‘biobank’ to illustrate how the shape and texture of policy discussions surrounding the use of donated blood for genetic research have been built upon a prior national consensus that regarded blood as a public good.


Introduction

  1. Top of page
  2. Abstract
  3. Introduction
  4. Blood donation in the UK: social and political landscapes
  5. The emergence of an ‘informational’ economy
  6. The development of UK Biobank
  7. Science governance in the UK
  8. Bodies of experts and the governance of medical research
  9. Blood and commerce: ‘gift’ as a mediating concept
  10. Conclusions
  11. Acknowledgements
  12. References

Recent years have witnessed the emergence of a number of large-scale national and regional genetic biobanks3. One irony of this development is that countries with a national health system and comprehensive population health records are of particular interest to commercial organisations, which view such systems as a unique resource that contains valuable, well-characterised data (Fears and Poste 1999). Importantly, in the cases of Iceland, Estonia, and now the UK, this private commercial interest dovetails with national economic strategies aimed at promoting biotechnology as an indispensable component of a modern knowledge economy (Rose 2001, Fletcher 2004, Biotechnology Innovation and Growth Team [BIGT] 2003). Both government planners and biotechnology entrepreneurs envisage public-private partnerships. The eventual success of these ventures depends upon participation of national populations. Citizen participation involves populations of interest donating blood samples and making information about themselves available for use in multiple unspecified research projects over a long-term period. Although in all cases public officials who advocate the development of biobanks expect a significant level of commercial involvement, each national plan has markedly different aims, operational arrangements and regulatory regimes. The development of such biobanks, then, poses new challenges for policy-makers, regulators and the bioethicists who are consulted on questions of public policy4. In the face of both a growing awareness of the multinational holdings of such data and the ease of circulating these data, a prominent approach has been to call for the information in biobanks to be treated as ‘global public goods’ (Human Genome Organisation [HUGO] Ethics Committee 2003)5.

In this paper I use an historical approach to understand the framing of policy debates about genetic databases and biobanks in the UK to date. The rationale for analysing a distinctive ‘British’ approach to these debates is to provide an empirical case to explore Jasanoff's observation that political culture shapes debates about biotechnologies in significant and important, if unappreciated, ways (Jasanoff 2005: 12). An important dimension for understanding ‘ethics’ involves showing how presumptively ‘natural’ and taken-for-granted assumptions about the ‘right’ way to organise biobanks, or for that matter any public good, are embedded within tacit cultural schema, social structures and collectively shared historical narratives.

Blood donation in the UK: social and political landscapes

  1. Top of page
  2. Abstract
  3. Introduction
  4. Blood donation in the UK: social and political landscapes
  5. The emergence of an ‘informational’ economy
  6. The development of UK Biobank
  7. Science governance in the UK
  8. Bodies of experts and the governance of medical research
  9. Blood and commerce: ‘gift’ as a mediating concept
  10. Conclusions
  11. Acknowledgements
  12. References

In Britain, technologies of blood donation are widely accepted, having first been used systematically for the treatment of war casualties. Indeed, blood donation became woven into a myth of nationhood in which altruism and solidarity featured prominently. A blood service organised around the principles associated with the National Health Service (NHS) was established shortly after the foundation of the health service itself (National Blood Authority 1996). The idea of a blood service resonated with these principles and ideals, drawing on images of aristocrats and commoners alike responding to war-time emergencies by queuing to donate blood.

Titmuss’ The Gift Relationship (1970) portrays a period in which blood donation was conceived of as an altruistic act within a framework of national solidarity. This paradigm continued to hold sway over the following several decades. Ironically, in the clinical and policy literature on blood donation, an interpretation of Titmuss has been taken up that heralds donated blood as an indicator of the altruism of individual blood donors. This interpretation transforms a book about the social organisation of health services with particular reference to blood donation into a celebration of individual altruism. This distorted and highly truncated reading of Titmuss continues to be pressed into service in the ongoing policy debates about the nature of biobanks as a national resource (Busby 2004).

Of all the national institutions in the UK, the NHS became a symbol of shared provision for the common good, and has an iconic place in British political life (Page 1996). Just as the political and welfare settlement of the post-war years shaped the history of the NHS, so did it shape the development of a blood service that was famously different from the US commercial market system: blood banks in Britain were to be sustained by the free, unpaid donations of citizens (Oakley 1996). To foreshadow the discussion below, the image of the early years of the blood service shaped the language for policy discussions about the use of donated blood and tissue in subsequent years. As a consequence, formative discussions about the emergence of global markets in the information derived from blood were shaped by associations of gifted blood, that, because of their long history in political discourse in the UK, were arguably even more influential than declarations issued by international organisations.

Meanwhile, despite an unchanging quality of discussions about blood in political arenas, technological developments in the use of blood during the 1970s and 1980s rendered the system almost unrecognisable from the system described by Titmuss. The uptake of technologies for more effective blood testing combined with more stringent selection of donors eroded the notion of universal blood donation (Martlew 1997). Moreover, the notion of a national blood supply was undermined by the practice of importing blood from other nations when required (O’Neill 2003). Finally, the National Blood Service (NBS) that eventually incorporated the precursor local and regional services developed an expanded portfolio of activities that included the banking of a range of human tissues, as well as undertaking research using donated blood. Nevertheless, the trust that donors place in the NBS remains informed by the politically potent cultural image of a national blood bank existing to provide immediate help to NHS patients who encounter accidents or serious illness (Busby 2004). Questions of identity are rarely raised in relation to blood donated in these contexts, nor are the processes of transforming raw blood into blood products seen as problematic. For these reasons amongst others, the uses of blood donated to the NBS have escaped close scrutiny or definition as problematic ‘ethical issues’.

The emergence of an ‘informational’ economy

  1. Top of page
  2. Abstract
  3. Introduction
  4. Blood donation in the UK: social and political landscapes
  5. The emergence of an ‘informational’ economy
  6. The development of UK Biobank
  7. Science governance in the UK
  8. Bodies of experts and the governance of medical research
  9. Blood and commerce: ‘gift’ as a mediating concept
  10. Conclusions
  11. Acknowledgements
  12. References

Historically, in Britain, the act of donating blood provided – or was at least thought to provide – a direct benefit to others in one's community. The management of such blood was a domain outside of and separate from commercial markets. However, the uses to which donated blood are put have diversified throughout the second half of the 20th century. Recent technological developments allow for genetic analyses to be undertaken on a large scale with small samples of blood (Hirztlin et al. 2003). Consequently, donated samples have become an immensely valuable resource for both commercial and public health research. The involvement of new commercial actors, notably pharmaceutical companies, has contributed to the emergence of an ‘informational economy’ within which blood is exploited (Tutton 2002: 537).

At the same time, products derived from donated blood continue to be essential in the treatment of patients following blood loss in serious accidents and acute illnesses. Despite attempts to manufacture synthetic blood, medical treatments still rely on donated blood and other corporeal donations. Blood has become a valuable commercial resource while it remains an irreplaceable public good. The dual nature of blood provides a certain elasticity to the deployment of blood and blood products in public discourse. Policy advocates for development of biobanks find it quite easy to switch registers in their framings – here it is a public good and then in a flash it is a resource to be exploited in the development of the new information economy – blood in political discourse is both priceless and valuable.

Commercial companies have for some time held banks of donated tissue, often from their own clinical trials or from public sources such as hospitals, and there is an established trade in the information derived from such tissue (Lewis 2004). In addition to the development and expansion of commercial tissue banks, population biobanks that draw on data across a regional or national population via public health systems exist in a number of countries. In general, such biobanks propose to obtain broad consent for an unspecified set of studies and for an undefined period of time (Austin et al. 2003). In the UK case, the stated rationale for investment in a national biobank is to provide a resource for commercial and public health research (Medical Research Council [MRC] 2002). Although plans to develop a new national biobank have generated only a limited public debate in the UK, the initiative has the potential for considerable controversy, destabilising the consensus about the basis for the state's involvement in blood and tissue banking.

My research focuses on the role of expert bioethics bodies in the intersecting debates about the banking and uses of donated blood and tissues for medical research. In this context, ideas of ‘altruism’ and gifted blood have been wrenched from the post-war sentiments in which they were sedimented, and now circulate through these debates, providing an apparently unifying reference point to what are, in fact, highly divergent positions.

The development of UK Biobank

  1. Top of page
  2. Abstract
  3. Introduction
  4. Blood donation in the UK: social and political landscapes
  5. The emergence of an ‘informational’ economy
  6. The development of UK Biobank
  7. Science governance in the UK
  8. Bodies of experts and the governance of medical research
  9. Blood and commerce: ‘gift’ as a mediating concept
  10. Conclusions
  11. Acknowledgements
  12. References

For some time, there has been in the UK a number of known collections of tissue and genetic information, most of which are disease specific, and enrol participants through clinicians in contact with patients with the specified disorder. In addition, there is an established national ‘blood spot’ collection from newborn babies screened for phenylketonuria (PKU)6. More recently, several regional collections of genetic data have been established (Chase et al. 1998, see also http://www.alspac.bris.ac.uk). The idea for a national biobank was initially proposed in 1998 when the Medical Research Council (MRC) was given additional funds to establish a DNA collection (Barbour 2003). An expert panel published a report on a DNA collection in March 2000, recommending the creation of two prospective cohort studies, one of middle-aged people, and the other a birth cohort. The idea of studying a cohort of middle-aged people (aged 45–69) has been taken forward on the assumption that as the older cohort aged, the normal morbidity associated with ageing would provide useful data sooner (Barbour 2003). At government level, the project, now known as UK Biobank, is nested within a series of policy initiatives designed to secure a place for the UK in the emerging global knowledge economy. Its sponsors’ efforts at consultation and market research notwithstanding, critics argue that a closed circle of decision-makers has prevented the project's scientific rationales and protocols from being subject to open scrutiny and genuine public debate7.

The UK Biobank recently confirmed that it will recruit its subjects through the NHS. Participating subjects allow access to their health records on an ongoing basis, answer detailed health and lifestyle questionnaires and provide blood samples. Potential subjects will be asked to give their ‘broad consent’ to the use of their tissue and data for public and commercial research. Potential subjects will consent or refuse to participate in the Biobank in its entirety, but will not be informed, in advance, of the purpose of the research for which their samples and data will be used (UK Biobank 2004, Newton 2004). This stipulation adds a dimension of uncertainty and contingency to the burden of obtaining ‘informed consent’8. Despite calls for greater community involvement no plans currently exist to involve donors or the wider collectivity in discussions about the priorities and boundaries for the UK biobank (GeneWatch 2003, Kaye 2004, Tutton, Kaye and Hoeyer 2004, Williams and Shroeder 2004)9.

Science governance in the UK

  1. Top of page
  2. Abstract
  3. Introduction
  4. Blood donation in the UK: social and political landscapes
  5. The emergence of an ‘informational’ economy
  6. The development of UK Biobank
  7. Science governance in the UK
  8. Bodies of experts and the governance of medical research
  9. Blood and commerce: ‘gift’ as a mediating concept
  10. Conclusions
  11. Acknowledgements
  12. References

No major political or parliamentary debate about the development of a national biobank in the UK has taken place. Given the absence of a wide-ranging political debate, experts who have been asked to advise on the development of the UK Biobank have a curious role to play. Selected on the basis of their expertise in particular fields, they are implicitly being asked to identify policies acceptable to a wider public. While this is not an unusual role for bioethicists, it nonetheless conflates the policies that are deemed socially and politically possible with those that are considered ‘acceptable’. The rationale for adopted policies then becomes hard to locate. What criteria are used to determine what is socially and politically ‘acceptable’? Whose interests are represented in such determinations? How are conflicts resolved when policies are acceptable to one group but not another? Because the policy role of the bioethics adviser substitutes rule by experts for more inclusive democratic processes, opaqueness replaces transparency in the formulation of policy.

Because many of these expert groups have been only recently established, analysis of the role they play in British public life is only beginning to emerge. In the US, where public bioethics bodies have played a more prominent role in policy-making and agenda-setting, Kelly (2002) has suggested that such bodies are ‘flexible but stable spaces in which scientists and other interested bodies struggle over the boundaries between science and politics . . .’ and called ‘for greater attention to the complex relationship between ethics, science, and policy in governance’ (2003: 357). The ‘discursive ambiguity’ (Kelly 2003: 357) that Kelly identifies as a feature of ethics advisory bodies in the US has a parallel in the multivalent notion of gifted blood in the UK.

‘Public anxieties over technical change have become a recognised feature of science and technology policy’, in the UK and a number of other European countries (Irwin 2006). The problem of trust is particularly acute when issues of human genetics are involved (Jones and Salter 2003: 21). Public officials have responded to these perceived crises through strategies to promote public engagement and civic participation at various levels of government. Nonetheless, one area of policy rarely considered within the scope of public participation is the regulation of commercial involvement in research (Kerr 2003). This is so even though new intersections of public information and private enterprise pose new community-level challenges.

In the UK, as elsewhere, the cultural and economic importance of retaining a leading role in the development of biotechnology is a recurrent theme within government and policy debates. Early discussions about a national biobank project referred to innovation, international competitiveness and the UK's place in the global knowledge economy. Advocates for the development of the biobank claimed that partnerships between the NHS and commercial organisations were critical for realising the government's scientific and economic agenda (Gould 2003). The 2003 Genetics White Paper highlights the kind of collaboration sought by government (Department of Health 2003). A recent official report by the Department for Trade and Industry's BIGT, argues for the promotion of clinical research in the UK:

The NHS is a unique institution globally, providing a gateway to the largest single pool of patients in the world, and caring for those patients from cradle to grave . . . The NHS should be a leader in clinical innovation, with the infrastructure and the expertise to support cutting edge clinical research that improves patient care. Such a capability would provide a significant competitive advantage for the UK bioscience sector, which no other country would be able to match. It would act as a clear incentive for companies to establish themselves in the UK (BIGT 2003: 7).

The aim of keeping ‘at the forefront of modern health research and technology’ (MRC 2002) encompasses the twin goals of providing health benefits and generating wealth through the biotechnology industry.

Although a view of the NHS as a resource for the national economy is evident in these policy statements, mechanisms for both recognising and then reconciling conflicts with more traditional concepts of welfare have not as yet been addressed. In particular, the implications of deploying the NHS patient population as a ‘central resource for an emerging market in genetic information’ (Martin 2001: 181) are rarely addressed in these discussions. Nor do the new regulatory and governance frameworks, described below, fully confront the challenges the absorption of patient information into ‘novel regimes of ownership, informed consent and privacy’ present to balancing commercial with community and individual interests (Brown and Webster 2004: 96, see also Brown and Rappert 2000). In summary, a new agenda for medical research involving extensive public-private collaborations has emerged within a more traditional framework that fails to acknowledge conflicts, tensions and disjunctures between commercial interests and public sector research.

Bodies of experts and the governance of medical research

  1. Top of page
  2. Abstract
  3. Introduction
  4. Blood donation in the UK: social and political landscapes
  5. The emergence of an ‘informational’ economy
  6. The development of UK Biobank
  7. Science governance in the UK
  8. Bodies of experts and the governance of medical research
  9. Blood and commerce: ‘gift’ as a mediating concept
  10. Conclusions
  11. Acknowledgements
  12. References

Traditionally, regulation of medical research in the UK has depended very much on self-regulation by the medical profession (Martin 2001, Hazlegrove 2002). However, the initiative to develop a national UK biobank coincided with a period of change in both the political landscape and the regulation and governance of medical research in the UK. For the NHS itself, this overhaul culminated in a new regulatory framework that replaced a traditional reliance on professional codes of ethics with legal statutory requirements on institutions, including NHS trusts (Department of Health 2001, Kerrison, McNally and Pollock 2003).

Public debate and regulatory innovation surrounding the treatment of genetic data in medical research focused primarily on the ‘stuff’ of blood or tissue. The conjunction of the early discussions about the biobank with an intense debate about the use of human tissue in medical research, followed and, to some extent, was a consequence of the discovery of the use of organs retained in hospitals and research institutes after post-mortem without relatives’ consent (Hansard 2003). The enactment of the amended Human Tissue Act 2004 can be seen as a compromise between the government's desire to put patients’ consent at the heart of the legislation and the research lobby's requirements. By announcing its intention to make the unauthorised use of DNA analysis an offence, the government made a symbolic statement about a new regime in which patients’ interests were more explicitly underscored. Meanwhile, a more expansive archiving of NHS patient information, an activity crucial to the biobank project, has attracted less attention. Despite attempts to clarify the legal rules that protect individual medical records, there is a good deal of uncertainty about the new regulatory regime (McHale 2004). For example, how the differing and often competing interests and voices of the various stakeholders in medical research in the UK are to be resolved remains an open question of critical salience.

Unlike some other European countries, the UK has no national bioethics committee. As a result, a shifting, informal ad hoc network of local, national and international expert bodies informs and shapes discussion of developments in the biosciences. National Health Service research ethics committees are primarily concerned with regulating clinical research involving NHS patients and staff. Current guidelines for the review of research protocols do not require consideration of the collective implications of proposed research and it is not clear that an ethics committee has the authority to attempt such a review.

The most prominent of the non-governmental bioethics bodies in the UK, The Nuffield Council, was established in 1991 ‘to identify, examine and report on the ethical questions raised by recent advances in biological and medical research’. The Nuffield Council subsequently received support and funding from the Wellcome Trust and the MRC. Council members are mostly senior clinicians, lawyers and philosophers. The MRC plays a major role in this policy network if only because it has established behavioural standards that operationalise the ethical guidelines to which its funded researchers must adhere. The MRC is a powerful agent and policy advocate in its own right, proposing guidelines for the use of human tissues in research and lobbying the government on the Human Tissue Bill10. Drawing on its position as the major non-governmental funder of medical research in the UK, The Wellcome Trust also plays a significant role in sponsoring conferences that often serve as a first step in articulating frameworks for discussion of research ethics and governance. These organisations distribute intellectual, social, cultural and political capital to experts whose credibility rests on the investments made in them.

Despite this selective and focused investment, an absence of social consensus about biotechnologies in particular and science in general has allowed a proliferation of expert groups in this domain. Amongst these, the Human Genetics Commission (HGC) is the organisation most relevant to this discussion. At the government's request, the HGC has provided advice for and published a number of reports on the use of human genetic information. The HGC has extended its role to include conducting consultations and commissioning surveys on the public perceptions of these issues (HGC 2000, 2002). The task of promoting dialogue with members of the public has fallen to, or been seized by, the HGC, to a greater extent than is typically the case with expert advisory groups in the UK. The HGC is more explicitly involved in negotiating, establishing and reinforcing a consensus in this field (Jones and Salter 2003).

Both the Nuffield Council and the HGC place their advice in the context of the network of international bodies that effectively make up an ‘international genre of ethical and social decision-making’ (Kerr 2003: 148). Amongst these is the Human Genome Organisation (HUGO) ethics committee, which has published ethical guidelines on genetic research and more specifically on the use of genetic databases (HUGO 1996, 2003). Genetic databases are depicted as ‘global public goods’ in these guidelines and recommendations are made for benefit sharing. However – as in other areas of bioethics – transactions between individuals are easier to propose and to monitor than those across the wider social fabric. In addition to the difficulties of providing both workable and enforceable operational definitions for benefit sharing, consensus has yet to be reached on international agreements that regulate the commercialisation of human tissue or products derived from it.

Another level of bioethical discussion takes place amongst the bodies advising the European Commission, such as the European Group on Life Sciences and the European Group on Ethics in Science and New Technologies to the European Commission (EGE). As Kerr has noted, the pronouncements, soundings and concrete advice of national and supranational expert bodies commonly restate but do not resolve the key questions raised by public-private partnerships in biotechnology:

The spirit of capitalism involves investment, innovation and scientific progress for the public good, balanced with the need to reward individuals and corporations for their inventions (Kerr 2003: 149).

As with these international discussions, discussions about genetic research in the UK have taken place against a backdrop of shifting relationships between commerce and the public sector.

Yet, in Britain, a powerful narrative about the NHS as a central component of the welfare state celebrates the role of that institution in mediating national identity and, historically, reinforcing a national solidarity. A counter-narrative that highlights the tensions at play between commercial interests and the values underlying the NHS is not part of political discourse. In the context of these shifting relationships the revival of the metaphor of donated blood as a gift puts a gloss on some very different ideas about how those relationships should be constituted and governed11.

Blood and commerce: ‘gift’ as a mediating concept

  1. Top of page
  2. Abstract
  3. Introduction
  4. Blood donation in the UK: social and political landscapes
  5. The emergence of an ‘informational’ economy
  6. The development of UK Biobank
  7. Science governance in the UK
  8. Bodies of experts and the governance of medical research
  9. Blood and commerce: ‘gift’ as a mediating concept
  10. Conclusions
  11. Acknowledgements
  12. References

Just as donated blood circulates through different contexts, so too does the trope of ‘the gift’ as a description of the relationships constituted by the voluntary donation of blood. The idea of gifted tissue appears in several phases. First, the Nuffield Council and the MRC published ethical guidelines on the use of human tissue in medical research. These guidelines became necessary as a consequence of emerging controversies about the patenting of genetic information (Nuffield Council 1995, MRC 2001). Initially, the issue was mainly conceived as one of professional ethics. Next, appeals to patient altruism served as a basis for discussions addressing the policy frameworks about the uses of genetic information and genetic databases. These discussions explicitly ask the public to provide help for future generations of NHS patients. Appeals to professional ethics, on the one hand, and patient altruism, on the other, are powerful because of the echoes they find in the views of donors and other members of the public.

The Nuffield Council's report Human Tissue: Ethical and Legal Issues reviewed the ethics of the use of human tissue, including new problems arising from applications for gene patenting. In summarising its conclusions, the report refers to the importance of ‘the gift relationship’ between donors and recipients, without referencing Titmuss’ work directly (Nuffield Council 1995: 68). Similarly implicit reference to Titmuss’ work is made in the MRC's guidelines on the use of human tissue (MRC 2001). Tutton's analysis of these guidelines places them squarely in the context of commercial interests’ involvement in biomedical research and the public uncertainty surrounding the acceptability of such involvement (Tutton 2004). Both the MRC and the Nuffield Council seek to protect human tissue from commodification, whilst also underscoring the necessity of commercial involvement in research.

If we pursue the proposals for the use of human tissue further, we find that the metaphor of the gift is used to describe the transfer of property. This signification of gift, indicating that tissue, having been freely given, becomes the property of the researcher or institutional custodian, is one that was already used in consent forms for research participants. The gift language of professional guidelines formalises an ethical discourse, incorporating while delimiting property rights for the use of tissue. The subsequent distinction between tissues themselves and the information derived from them, begins to allow ‘a boundary to be delineated between two economies, that of non-commercial tissue donation complete with a discourse of altruism, and the commercial realm of genetic information that can be transformed into property’ (Tutton 2004: 33). If products do eventually come to market as a result of use by commercial companies of a public biobank, these delineations will be extremely important. The Biobank's ‘Draft Intellectual Property (IP) Strategy’ states that ‘intellectual property arising out of research using the resource will vest in the investigator creating it, his or her institution, or in appropriate cases, their assignees’ (UK Biobank 2005).

Subsequently, the image of altruistic blood donation, as a ‘gift to strangers’ was revived in discussions about tissue donation for genetic research in general and proposals for a national biobank in particular. In the House of Lords report on Human Genetic Databases, for example, the principle of establishing a national biobank is strongly endorsed, and members of the public are asked to provide help for future generations (House of Lords 2001). The ideal of ‘genetic solidarity and altruism’ as one of the bases for public policy in this field was subsequently made explicit by the HGC, and reiterated in the Government's Genetics White Paper (HGC 2002: 18, Department of Health 2003: 78). References to citizenship and altruism and – again – to the desirability of seeing donated blood as a gift are also featured in industry workshops undertaken by the UK Biobank (UK Biobank 2003). Importantly, these references are echoed in the findings of focus groups with potential participants conducted on behalf of the Biobank (People, Science and Policy 2002: 11).

When we unpack the discourse of patient and donor altruism in the context of the development of a UK biobank, we see that the gift metaphor is not a rhetoric imposed on an unwilling public. Rather, the power of the particular public representations of gifted blood lies in the extent to which they mobilise associations about the NHS and welfare state. However, the invocation of selfless altruism sits uneasily with more politically and historically informed ideas about the NHS, which stress mutual interests as the basis for it and related welfare institutions (Baldwin 1990). Further, it is difficult to find a logical place for them in an information economy where the value of genetic material and data is measured in commercial terms.

Conclusions

  1. Top of page
  2. Abstract
  3. Introduction
  4. Blood donation in the UK: social and political landscapes
  5. The emergence of an ‘informational’ economy
  6. The development of UK Biobank
  7. Science governance in the UK
  8. Bodies of experts and the governance of medical research
  9. Blood and commerce: ‘gift’ as a mediating concept
  10. Conclusions
  11. Acknowledgements
  12. References

Social scientists and ethicists are only now beginning to confront the implications of new inter-relationships between genetic research, commerce and the state. A critical focus for examining these inter-relationships is the formation of national biobanks to promote commercial ventures in genetic research. Whereas some bioethicists in their role as ‘legislative intellectuals’ focus on policies that are formed to reflect universal principles, social scientists are more concerned with examining the fit between the rhetoric invoking universal principles and the practices – the bundle of tasks, work routines and social accounts – said to reflect these principles (Haimes 2002, Bauman 1992: 11, Bosk 1999). Both bioethicists and social scientists use, although often in different ways, a language that depends upon distinctions between ‘public’ and ‘private’, and references to altruistic behaviour and the metaphor of gift. These same terms, when used in policy discussions, often mirror the discourse of bioethicists and social scientists.

As UK Biobank moves towards a more detailed consideration of the policy questions it confronts, invocations of altruism have receded. Nevertheless, the legacy of this approach is contained in many iterations of public policy. In the midst of uncertainty and controversy surrounding contemporary developments in genetic research, the utility of the concept of altruism in a policy context is found in its fluidity. Depending on the context, altruism refers to the generosity of individual donors or to the appropriate response of citizens to promised therapeutic developments in genetic research and to the national commercial benefits that they will provide. The appeal to altruism, however, when combined with the metaphor of donated blood as ‘gifted’, has come to obscure the choices that are to be made about the organisation and boundaries of a public genetic research biobank. The nostalgic cast of this metaphor has obscured discussion about the research uses of diverse collections of genetic material held by public bodies in the UK, and has limited the scope of formative policy discussions about oversight of the new national biobank.

Notes
  • 1

    See Knoppers (2005) for a review of international declarations and norms on bioethics and biobanking.

  • 2

    For Bauman, writing primarily about an earlier era of modern intellectuals, legislative authority ‘involved the right to command the rules the social world was to obey . . . was legitimised in terms of a better judgement, [and] a superior knowledge guaranteed by the proper method of its production’ (Bauman 1992: 11).

  • 3

    Population genetic biobanks hold data and tissue samples for very large numbers of people, selected on demographic criteria from the members of a regional or national population (Austin et al. 2003, Kaye 2004)

  • 4

    Increasingly, an analysis of the ethics of blood donation and of the collection of genetic material must take account of global flows in the circulation and exchange of such material and related data (Parry 2004). However, this paper cannot describe the global flows of such data, not only because of limitations of space, but also because further empirical work is needed to track these flows.

  • 5

    My own view is that national biobank projects enrol participants through reference to an imagined national community (Busby and Martin forthcoming, with reference to Anderson [1991]). I have therefore advocated that their organisational hosts and sponsors pay more attention to the question of ethical and geographic boundaries than has been done to date, and explore the acceptable limits of commercial exploitation of genetic data amongst these communities (Busby 2004).

  • 6

    The PKU screening programme began in the 1960s, and was extended to a national programme in which blood spot cards were stored. These small blood samples are routinely held for five years, with a consultation underway about a further extension of storage and research use (Oliver et al. 2005).

  • 7

    See Wallace (2002), and the reply by Radda et al. (2002). The scientific and ethical peer reviews were subsequently made public after the GeneWatch group called for their release under the Freedom of Information Act. These reviews can now be seen on the MRC's website at <http://www.mrc.ac.uk/strategy-biobank> (Accessed November 2005).

  • 8

    Longstanding critiques of informed consent, i.c., as a pillar of ethical relations between researchers and human subjects, are to some extent complicated by this notion of broad consent. Those opposing i.c. on the grounds that it is difficult, impossible or burdensome for individuals to assess information about research projects, might conceivably find comfort in the notion of broad consent. The issue of has been discussed extensively. See, for example, Wolpe (1998) on the trajectory and application of the principle of autonomy and its analogue in American bioethics; Corrigan (2003) for a recent critique of the positions taken in the UK, and Kaye (2004) for a specific critique of the application of ‘broad consent’ in the context of UK Biobank.

  • 9

    An Ethics and Governance Advisory Council is charged with advising on the compliance of its own Ethics and Governance Framework, and ‘more generally on operating in accordance with the interests of participants and the general public’. (http://www.ukbiobank.ac.uk/ethics)

  • 10

    The Bill as originally conceived involved a degree of emphasis on patient consent which was seen to compromise the interests of the research community. See Hansard (2003).

  • 11

    I draw here on the idea of a ‘mobilising metaphor’, developed by Shore and Wright in their work on the language of policy and the construction of legitimacy (Shore and Wright 1997: 20).

Acknowledgements

  1. Top of page
  2. Abstract
  3. Introduction
  4. Blood donation in the UK: social and political landscapes
  5. The emergence of an ‘informational’ economy
  6. The development of UK Biobank
  7. Science governance in the UK
  8. Bodies of experts and the governance of medical research
  9. Blood and commerce: ‘gift’ as a mediating concept
  10. Conclusions
  11. Acknowledgements
  12. References

My thanks go to Robert Dingwall and Paul Martin. I would also like to acknowledge a recent doctoral training grant from the Wellcome Trust Biomedical Ethics programme, and the support of a postdoctoral fellowship from the ESRC. Conclusions drawn, however, are my own, and do not represent the views of these organisations.

References

  1. Top of page
  2. Abstract
  3. Introduction
  4. Blood donation in the UK: social and political landscapes
  5. The emergence of an ‘informational’ economy
  6. The development of UK Biobank
  7. Science governance in the UK
  8. Bodies of experts and the governance of medical research
  9. Blood and commerce: ‘gift’ as a mediating concept
  10. Conclusions
  11. Acknowledgements
  12. References
  • Anderson, B. (1991) Imagined Communities. London: Verso.
  • Austin, M., Harding, S. and McElroy, C. (2003) Monitoring ethical, legal, and social issues in developing population genetic databases, Genetics in Medicine, 5, 6, 4517.
  • Baldwin, P. (1990) The Politics of Social Solidarity. Cambridge: Cambridge University Press.
  • Barbour, V. (2003) UK Biobank: a project in search of a protocol? The Lancet, 361, 17348.
  • Bauman, Z. (1992) Legislators and interpreters: culture as the ideology of intellectuals. In Bauman, Z. Intimations of Postmodernity. London: Routledge.
  • Biotechnology Innovation and Growth Team (2003) Bioscience 2015: Improving National Health, Increasing National Wealth. http://www.dti.gov.uk/bio-igt/downloads.html. Department for Trade and Industry.
  • Bosk, C.L. (1999) Professional ethicist available: logical, secular, friendly, Daedalus, 128, 4768.
  • Brown, N. and Rappert, B. (2000) Emerging bioinformatic networks: contesting the public meaning of private and the private meaning of public, Prometheus, 18, 43752.
  • Brown, N. and Webster, A. (2004) New Medical Technologies and Society: Reordering Life. Cambridge: Polity Press.
  • Busby, H. (2004) Reassessing the ‘gift relationship’: exploring the meaning and ethics of blood donation for genetic research. Unpublished PhD Thesis: University of Nottingham.
  • Busby, H. and Martin, P. (2006) National Biobanks and imagined communities: the case of UK Biobank, Science as Culture, 15, 3, 237–51.
  • Chase, D., Tawn, E., Parker, L., Jonas, P. and Burn, J. (1998) The North Cumbria Community Genetics Project, Journal of Medical Genetics, 35, 41316.
  • Corrigan, O. (2003) Empty ethics: the problem with informed consent, Sociology of Health and Illness, 25, 3, 76892.
  • Department of Health (2001) Department of Health Research Governance Framework for Health and Social Care. London: Department of Health.
  • Department of Health (2003) Our Inheritance, our Future: Realising the Potential of Genetics in the NHS. HMSO (Cm 5791-II).
  • Fears, R. and Poste, G. (1999) Building population genetics resources using the UK NHS, Science, 284, 2678.
  • Fletcher, A. (2004) Field of genes: the politics of science and identity in the Estonian gene project, New Genetics and Society, 23, 1, 314.
  • GeneWatch UK (2003) Main ethical questions about genetic sampling sidelined in biotech industry's favour: GeneWatch UK response to UK Biobank ‘Ethics and Governance Framework’ (Press Release). <http://www.genewatchuk.org/press> (accessed 10/11/2005)
  • Gould, M. (2003) Group calls for agency to boost UK bioscience industry, British Medical Journal, 237, 1183.
  • Haimes, E. (2002) What can the social sciences contribute to the study of ethics? Theoretical, empirical and substantive contributions, Bioethics, 16, 2, 89113.
  • Hansard (2003) Human Tissue Bill explanatory notes. http://www.parliament.the-stationery-office.co.uk/pa/cm200304/cmbills/009/en/04009x-.htm. London: The Stationery Office.
  • Hazelgrove, J. (2002) The old faith and the new science: the Nuremberg code and human experimentation ethics in Britain, 1946–73, Social History of Medicine, 15, 1, 10935.
  • Hirtzlin, I., Dubreuil, C., Preaubert, N., Duchier, J. et al. (2003) An empirical survey on biobanking of human genetic material and data in six EU countries, European Journal of Human Genetics, Vol 11, 47588.
  • House of Lords (2001) Fourth Report of the Select Committee on Science and Technology: Human Genetic Databases: Challenges and Opportunities. London: HMSO.
  • Human Genetics Commission (2000) Whose Hands on your Genes? A Discussion Document on the Storage, Protection and Use of Personal Information (Consultation document). London: Human Genetics Commission.
  • Human Genetics Commission (2002) Inside Information: Balancing Interests in the Use of Personal Genetic Data. London: Human Genetics Commission.
  • HUGO (Human Genome Organisation) Ethics Committee (1996) Statement on the principled conduct of genetic research. Reprinted in Bioethics, 1, 1, 323.
  • HUGO (Human Genome Organisation) Ethics Committee (2003) Statement on Human Genetic Databases. Reprinted in Bioethics, 1, 1, 389.
  • Irwin, A. (2006) The politics of talk: coming to terms with the ‘new’ scientific governance, Social Studies of Science, 36, 2, 299320.
  • Jasanoff, S. (2005) Designs on Nature: Science and Democracy in Europe and the United States. Princeton: Princeton University Press.
  • Jones, M. and Salter, B. (2003) The governance of human genetics: policy discourse and constructions of public trust, New Genetics and Society, 22, 1, 2141.
  • Kaye, J. (2004) Abandoning informed consent: the case of genetic research in population collections. In Tutton, R. and Corrigan, O. (eds) Genetic Databases: Socio-ethical Issues in the Collection and Use of DNA. London: Routledge.
  • Kelly, S. (2003) Public bioethics and publics: consensus, boundaries, and participation in biomedical science policy, Science, Technology and Human Values, 28, 3, 33964.
  • Kerr, A. (2003) Governing genetics: reifying choice and progress, New Genetics and Society, 22, 2, 14358.
  • Kerrison, S., McNally, N. and Pollock, A. (2003) United Kingdom research government strategy, British Medical Journal, 327, 5536.
  • Knoppers, B.M. (2005) Biobanking: international norms, The Journal of Law, Medicine and Ethics, 33, 1, 714.
  • Lewis, G. (2004) Tissue collection and the pharmaceutical industry. In Tutton, R. and Corrigan, O. (eds) Genetic Databases: Socio-ethical Issues in the Collection and Use of DNA. London: Routledge.
  • Martin, P. (2001) Genetic governance: the risks, oversight and regulation of genetic databases in the UK, New Genetics and Society, 20, 2, 15783.
  • Martlew, V. (1997) Transfusion medicine towards the millennium. In Oakley, A. and Ashton, J. (eds) The Gift Relationship: from Human Blood to Social Policy, by Richard Titmuss. London: LSE Press.
  • McHale, J. (2004) Regulating genetic databases: some legal and ethical issues, Medical Law Review, 12, 1, 7096.
  • Medical Research Council (2001) Human tissue and biological samples for use in research: operational and ethical guidelines. London: MRC.
  • Medical Research Council (2002) The UK Biobank study gets funding go-ahead. http://www.mrc.ac.uk/index/public-interest/public-news-4/public-news_archive/public-news_archive_1_2002/public-biobank_uk.htm. (Accessed 10/5/2004.)
  • National Blood Authority (1996) National Blood Authority Annual Report 1996. London: National Blood Authority.
  • Newton, J. (2004) UK Biobank briefing note. http://www.ukbiobank.ac.uk/Documents/long%20briefing%20paper.pdf. (Accessed 3/11/2004)
  • Nuffield Council on Bioethics (1995) Human Tissue: Ethical and Legal Issues. London: Nuffield Council on Bioethics.
  • Oakley, A. (1996) Blood donation – altruism or profit? British Medical Journal, 312, 1114.
  • Oliver, S., Stewart, R., Hargreaves, K. and Dezateux, C. (2005) The Storage and Use of Newborn Babies’ Blood Spot Cards: a Public Consultation. London: Social Science Research Unit, Institute of Education, University of London.
  • O’Neill, K. (2003) A vital fluid: risk, controversy and the politics of blood donation in the era of ‘mad cow disease’, Public Understanding of Science, 12, 35980.
  • Page, R. (1996) Altruism and the British Welfare State. Aldershot: Avebury.
  • Parry, B. (2004) Trading the Genome: Investigating the Commodification of Bio-information. New York: Columbia Press.
  • People Science and Policy Ltd. (2002) Biobank UK: A Question of Trust. London: The Medical Research Council and The Wellcome Trust.
  • Radda, G., Dexter, M. and Meade, T. (2002) The need for independent scientific peer review of Biobank UK: Reply from UK Biobank, The Lancet, 359, 2282.
  • Rose, H. (2001) The commodification of bioinformation: The Icelandic Health Sector Database. http://www.wellcome.ac.uk/assets/WTD003281.pdf, 2001. http://www.wellcome.ac.uk
  • Shore, C. and Wright, S. (1997) Policy: a new field of anthropology. In Shore, C. and Wright, S. (eds) Anthropology of Policy: Critical Perspectives on Governance and Power. London: Routledge.
  • Titmuss, R. (1970) The Gift Relationship. London: Allen and Unwin.
  • Tutton, R. (2002) Gift relationships in genetic research, Science as Culture, 11, 4, 52342.
  • Tutton, R. (2004) Person, property and gift: exploring languages of tissue donation to biomedical research. In Tutton, R. and Corrigan, O. (eds) Genetic Databases: Socio-ethical Issues in the Collection and Use of DNA. London: Routledge.
  • Tutton, R. Kaye, J. and Hoeyer, K. (2004) Governing UK Biobank: the importance of ensuring public trust, Trends in Biotechnology, 22, 6, 2845.
  • UK Biobank (2003) Report of UK Biobank consultation with industry workshop. http://www.ukbiobank.ac.uk/docs/Industry-Workshop.pdf (accessed 01/09/04).
  • UK Biobank (2004) UK Biobank Ethics and governance framework: Summary of comments on version 1.0. http://www.biobank.ac.uk/ethics
  • UK Biobank (2005) UK Biobank: Policy on Intellectual Property (IP) and Access. Draft, 11 January 2005. London: MRC.
  • Wallace, H. (2002) The need for independent scientific peer review of Biobank UK, The Lancet, 359, 9325.
  • Williams, G. and Shroeder, D. (2004) Human genetic banking, New Genetics and Society, 23, 1, 89103.
  • Wolpe, P. (1998) The triumph of autonomy in American Bioethics: a sociological view. In De Vries, R. and Subedi, J. (eds) Bioethics and Society. New Jersey: Prentice Hall.